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The Medicines for Human Use (Clinical Trials) Regulations 2004

STATUTORY INSTRUMENTS 2004 No. 1031 MEDICINESThe Medicines for Human Use (Clinical Trials) Regulations 2004 Made - - - - 31st March 2004 Laid before Parliament 1st April 2004 Coming into force - - 1st May 2004 The Secretary of State, being a Minister designated(a) for the purposes of section 2(2) of the European Communities Act 1972(b) in relation to medicinal products, in exercise of the powers conferred by the said section 2(2), and of all other powers enabling him in that behalf, hereby makes the following Regulations : ARRANGEMENT OF Regulations PART 1 INTRODUCTORY and of a clinical for functions under the DirectivePART 2 ETHICS Kingdom Ethics Committees of ethics of ethics of and operation of ethics functions of the AuthorityPART 3 AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE of Part for authorisation and ethics committee of investigational medicinal products for the purpose of clinical trials(a) 1972/1811.

amended(d); “doctor” means a registered medical practitioner(e); “EEA State” means a State which is a Contracting Party to the EEA Agreement; “EEA Agreement” means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992(f) as adjusted by the Protocol signed at Brussels on 17th March 1993(g);

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Transcription of The Medicines for Human Use (Clinical Trials) Regulations 2004

1 STATUTORY INSTRUMENTS 2004 No. 1031 MEDICINESThe Medicines for Human Use (Clinical Trials) Regulations 2004 Made - - - - 31st March 2004 Laid before Parliament 1st April 2004 Coming into force - - 1st May 2004 The Secretary of State, being a Minister designated(a) for the purposes of section 2(2) of the European Communities Act 1972(b) in relation to medicinal products, in exercise of the powers conferred by the said section 2(2), and of all other powers enabling him in that behalf, hereby makes the following Regulations : ARRANGEMENT OF Regulations PART 1 INTRODUCTORY and of a clinical for functions under the DirectivePART 2 ETHICS Kingdom Ethics Committees of ethics of ethics of and operation of ethics functions of the AuthorityPART 3 AUTHORISATION FOR CLINICAL TRIALS AND ETHICS COMMITTEE of Part for authorisation and ethics committee of investigational medicinal products for the purpose of clinical trials(a) 1972/1811.

2 (b) 1972 for ethics committee committee and appeal relating to ethics committee for authorisation to conduct a clinical procedure for clinical trials involving general medicinal procedure for clinical trials involving medicinal products for gene therapy procedure for clinical trials involving medicinal products with special trials conducted in third to clinical trial by the licensing by the or adapting rejected proposals for to the appropriate committee or the Medicines of clinical trialPART 4 GOOD CLINICAL PRACTICE AND THE CONDUCT OF CLINICAL clinical practice and protection of clinical trial of trial in accordance with clinical trial authorisation safety or termination of clinical trialPART 5 of adverse of suspected unexpected serious adverse trials conducted in third list of suspected serious adverse reactions and safety reportPART 6 MANUFACTURE AND IMPORTATION OF INVESTIGATIONAL MEDICINAL for authorisation to manufacture or import investigational medicinal for hospitals and health for manufacturing of application for manufacturing or refusal of manufacturing and effect of manufacturing of manufacturing authorisation of manufacturing and revocation of manufacturing authorisationPART 7 LABELLING OF INVESTIGATIONAL MEDICINAL 3 PART 8 ENFORCEMENT AND RELATED of enforcement provisions of the or misleading of due 9 MISCELLANEOUS of references to specified and other amendments to provisionsSCHEDULES1.

3 Conditions and principles of good clinical practice and the protection of clinical trial subjects 2. Additional provisions relating to ethics committees 3. Particulars and documents that must accompany an application for an ethics committee opinion, a request for authorisation, a notice of amendment and a notification of the conclusion of a trial 4. Appeal against unfavourable ethics committee opinion 5. Procedural provisions relating to the refusal or amendment of, or imposition of conditions relating to, clinical trial authorisations and the suspension or termination of clinical trials 6. Particulars that must accompany an application for a manufacturing authorisation7. Standard provisions for manufacturing authorisations 8. Procedural provisions relating to proposals to grant, refuse to grant, vary, suspend or revoke manufacturing authorisations 9.

4 Modification of the enforcement provisions of the Act subject to which those provisions are applied for the purposes of these Regulations 10. Consequential and other amendments of enactments 11. Revocations 12. Transitional provisions PART 1 INTRODUCTORY PROVISIONS Citation and commencement 1. These Regulations may be cited as the Medicines for Human Use (Clinical Trials) Regulations 2004 and shall come into force on 1st May 2004. 4 Interpretation2. (1) In these Regulations the Act means the Medicines Act 1968(a); adult means a person who has attained the age of 16 years; adverse event means any untoward medical occurrence in a subject to whom a medicinal product has been administered, including occurrences which are not necessarily caused by or related to that product; adverse reaction means any untoward and unintended response in a subject to an investigational medicinal product which is related to any dose administered to that subject; authorised health professional means (a) a doctor, (b) a dentist, (c) a nurse, or (d) a pharmacist.

5 Appropriate committee , for the purpose of any provision of these Regulations under which a function falls to be performed, means such committee established under section 4 of the Act for purposes which consist of or include any of those specified in section 4(3) of the Act as the authority performing that function considers appropriate in the circumstances; assemble , in relation to an investigational medicinal product, means (a) enclosing the product (with or without other medicinal products of the same description) in a container which is labelled before the product is sold or supplied, or used in a clinical trial, or (b) where the product (with or without other medicinal products of the same description) is already contained in the container in which it is to be sold or supplied, or used in a clinical trial, labelling the container before the product is sold or supplied, or used in a clinical trial, in that container, and assembly has a corresponding meaning.

6 Business , except in Schedule 2, includes a professional practice and includes any activity carried on by a body of persons, whether corporate or unincorporate; chief investigator means (a) in relation to a clinical trial conducted at a single trial site, the investigator for that site, or (b) in relation to a clinical trial conducted at more than one trial site, the authorised health care professional, whether or not he is an investigator at any particular site, who takes primary responsibility for the conduct of the trial; clinical trial means any investigation in Human subjects, other than a non-interventional trial, intended (a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products, (b) to identify any adverse reactions to one or more such products, or (c) to study absorption, distribution, metabolism and excretion of one or more such products, with the object of ascertaining the safety or efficacy of those products; Commission Directive 2003/94/EC means Commission Directive 2003/94/EC(b) laying down the principles and guidelines of good manufacturing practice for medicinal products for Human use and for investigational medicinal products for Human use.

7 (a) 1968 (b) OJ No. L262, , 5 conditions and principles of good clinical practice means the conditions and principles specified in Schedule 1; conducting a clinical trial includes (a) administering, or giving directions for the administration of, an investigational medicinal product to a subject for the purposes of that trial, (b) giving a prescription for an investigational medicinal product for the purposes of that trial, (c) carrying out any other medical or nursing procedure in relation to that trial, and (d) carrying out any test or analysis (i) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of the investigational medicinal products administered in the course of the trial, (ii) to identify any adverse reactions to those products, or (iii)

8 To study absorption, distribution, metabolism and excretion of those products, but does not include any activity undertaken prior to the commencement of the trial which consists of making such preparations for the trial as are necessary or expedient; container , in relation to an investigational medicinal product, means the bottle, jar, box, packet or other receptacle which contains or is to contain it, not being a capsule, cachet or other article in which the product is or is to be administered, and where any such receptacle is or is to be contained in another such receptacle, includes the former but does not include the latter receptacle; dentist means a person registered in the dentists register under the Dentists Act 1984(a) or entered in the list of visiting EEC practitioners under Schedule 4 to that Act; the Directive means Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, Regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for Human use(b); Directive 2001/83/EC means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for Human use(c), as amended (d); doctor means a registered medical practitioner(e).

9 EEA State means a State which is a Contracting Party to the EEA Agreement; EEA Agreement means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992(f) as adjusted by the protocol signed at brussels on 17th March 1993(g); electronic signature means data in electronic form which are attached to or logically associated with other electronic data and which serve as a method of authentication; European Economic Area means the European Economic Area created by the EEA Agreement; the European Medicines Agency means the European Agency for the Evaluation of Medicinal Products established by Council Regulation (EEC) No. 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for Human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products(h);(a) 1984 (b) OJ No.

10 L121, , (c) OJ No. L311, , (d)See Article 31 of Directive 2002/98/EC (OJ No. L33, , ) and Commission Directive 2003/63/EC (OJ No. L159, , ). (e)See Schedule 1 of the Interpretation Act 1978 ( ), as amended by paragraph 18 of Schedule 5 to the Medical Act 1983 ( ). (f) OJ No. L1, , (g) OJ No. L1, , (h) OJ No. L214, , 6 ethics committee means (a) a committee established or recognised in accordance with Part 2, (b) the Ethics Committee constituted by Regulations made by the Scottish Ministers under section 51(6) of the Adults with Incapacity (Scotland) Act 2000(a), or (c) the Gene Therapy Advisory Committee; export means export to a third country from an EEA State, whether by land, sea or air; the Gene Therapy Advisory Committee means the Gene Therapy Advisory Committee appointed by the Secretary of State to (a) consider and advise on the acceptability of proposals for gene therapy research on Human subjects, on ethical grounds, and (b) provide advice on developments in gene therapy research and their implications.